ArticleAdvances in radiation oncology2025
Real-World Medical Device Reports of SpaceOAR Hydrogel Spacer: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database.
Article in Advances in radiation oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Impact of Hydrogel Spacer on Radiation Proctitis After Prostate Cancer Radiation Therapy: A Large-Scale Claims Database Analysis.Advances in radiation oncology · 2026Article
- Toward Sex-Specific Biomaterials Innovation: A Perspective.ACS biomaterials science & engineering · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Increasingly, polyethylene glycol (PEG) hydrogel spacers are being used to help reduce rectal toxicity in men undergoing radiation therapy for prostate cancer. Device-related issues and patient event rates from the Manufacturer and User Facility Device Experience (MAUDE) were assessed to contextualize spacer reports in the United States. Methods and Materials: PEG hydrogel spacer medical device reports (MDRs) from January 1, 2015, through December 31, 2023, were collected from the MAUDE database, which reports suspected device-associated malfunctions, injuries, and deaths submitted to the United States Food and Drug Administration. United States sales data during the same period were obtained from the manufacturer. Reported rates of device-related and patient events were calculated by dividing MDRs by total units sold, recognizing that not all units sold are necessarily placed. Results: A total of 1005 unique MDRs reported from the United States for PEG hydrogel spacers were identified in the MAUDE database, and 251,836 spacer units were sold during the study period. Five deaths were reported, representing 0.002% of total units sold. The annual MDR rate increased from 0.00% in 2015 to 0.57% in 2023 (overall rate 0.40%). The most frequently reported device-related events were placement/positioning problems (0.295%) and adverse events without an identified device or use problem (0.084%). The most frequently reported patient events were "no clinical signs, symptoms, or conditions" or asymptomatic (0.175%), pain/discomfort (0.110%), infection (0.052%), fistula formation (0.037%), and hemorrhage/blood loss/bleeding (0.033%). Conclusions: With respect to estimated device usage in the United States, overall device-related events and patient event rates for PEG hydrogel spacers consistently remained below 1%, with the majority having minimal or no reported clinical consequence.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.